Home › Trials › NCT06490445

Using medical cannabis aerosol to treat diabetic nerve pain

A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain

Phase 2 Interventional Syqe Medical · NCT06490445

This study is testing if a medical cannabis spray can help people with diabetic nerve pain feel better when used alongside their usual treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment192 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSyqe Medical Industry-sponsored
Locations38 sites (Waitara, New South Wales and 37 other locations)
Trial IDNCT06490445 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a medical cannabis aerosol containing varying doses of Δ9-tetrahydrocannabinol (THC) administered via the Syqe Inhaler as an add-on treatment for diabetic peripheral neuropathic pain (DPNP). Participants will be randomized to receive either the cannabis aerosol or a placebo three times daily over a 15-week period, following a structured screening and treatment protocol. The study aims to assess not only pain relief but also the safety and tolerability of the treatment, with a target enrollment of 192 participants across multiple countries.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with a confirmed diagnosis of diabetic peripheral neuropathic pain who are not current users of cannabis products.

Not a fit: Patients who are currently using cannabis products or have used them within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from diabetic peripheral neuropathic pain.

How similar studies have performed: While the use of cannabis for pain management is gaining interest, this specific approach using a fixed-dose inhaler is relatively novel and has not been extensively tested in previous studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions.
2. Males and females aged between 18 (included) and 75 (included) years.
3. Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products.
4. Agree not to participate in other interventional clinical studies during participation in this study.
5. Treated with standard of care for DPNP, either duloxetine or gabapentin or pregabalin as monotherapy or combination of 2.
6. Not current cannabis products users, that is, participants who were previous cannabis products users for any reason but have not used cannabis products within 3 months of the screening visit, or participants who have never used cannabis products, that is, cannabis naïve participants.
7. A diagnosis of DPNP (at screening).
8. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.
9. Glycated hemoglobin (HbA1c) less than (\<) 9% at screening.
10. Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive.
11. Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization.
12. Agree not to drive or operate heavy machinery during the study treatment period.
13. Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the administration of study treatment on Day 1or be of non-child-bearing potential as defined in the protocol.
14. Participants of reproductive potential who are sexually active must use effective birth control methods.

Exclusion Criteria:

1. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol at screening or randomization, ability to complete the study, or study assessments.
2. Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
3. Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
4. Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.
5. Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
6. Liver disease or liver injury as indicated by abnormal liver function tests at screening.
7. History or presence of impaired renal function at screening
8. Presence of significant pulmonary disease at screening
9. Ongoing respiratory infection at screening.
10. History of acute coronary syndrome; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure.
11. Concomitant clinically significant cardiac arrhythmias, examples, sustained ventricular tachycardia, and second or third degree atrioventricular block without a pacemaker, or any other relevant cardiac disease in the judgment of the investigator.
12. History of clinically significant electrocardiograms (ECG) abnormalities, or any of the following ECG abnormalities at screening or baseline:

    * PR greater than (\>) 200 milliseconds (msec)
    * QRS complex \>120 msec
    * Fridericia QT correction formula (QTcF) greater than (\>) 450 msec
    * History of familial long QT syndrome or known family history of ventricular arrythmia.
    * Acute ischemic changes.
13. History or presence of mental illness evidenced as defined in the protocol.
14. Abnormal neurological condition or abnormal neurological examination at screening in judgment of investigator.

Where this trial is running

Waitara, New South Wales and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Peripheral Neuropathic PainDiabetesNeuropathyPainful diabetic neuropathyChronic Neuropathic PainDPNPCannabisMedical cannabis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.